Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis

Sponsor

Endo Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT00426985

Collaborator

(none)

330

Enrollment

Location

Duration (Months)

15.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with tendonitis or bursitis of the shoulder, elbow or knee

Condition or Disease	Intervention/Treatment	Phase
Tendonitis Bursitis	Drug: Ketoprofen Topical Patch 20%	Phase 3

Detailed Description

This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with tendonitis or bursitis of the shoulder, elbow or knee. Eligible patients will have tendonitis or bursitis or the shoulder, elbow or knee and will be randomized (1:1 ratio) to receive double-blind treatment with either the KTP or a matching placebo patch to be applied once daily for 21 days. Patients will return to the clinic for assessments on Day 3, Day 7, Day 14 and Day 21; a follow-up assessment will be conducted by telephone on Day 35. At each visit through Day 21, patients will rate their average pain intensity during daily activities and while at rest using the 11-point scale (range 0 to 10), and will rate their functional disability. Patients will also complete an electronic diary in which pain intensity and pain relief ratings will be recorded three times daily. The use of study treatment and rescue medication will be recorded in the diary each day. Ibuprofen will be provided as prn rescue medication.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

330 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase III Study of the Efficacy, Tolerability and Safety of Ketoprofen Topical Patch, 20% (KTP) in the Treatment of Pain Associated With Tendonitis or Bursitis of the Shoulder, Elbow or Knee

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

May 1, 2008

Anticipated Study Completion Date :

Oct 1, 2008

Outcome Measures

Primary Outcome Measures

Average pain intensity during daily activities []

Secondary Outcome Measures

Average pain intensity while at rest; use of prn rescue medication; patient's and physician's global assessments of study medication, MPI, Sleep []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Males or females 18 years of age or older
Diagnosis of tendonitis or bursitis of the shoulder, elbow or knee
Meet pain entry criteria
Willing to discontinue use of any pain medication not provided by study

Exclusion Criteria:

Have tendonitis or bursitis secondary to a systemic inflammatory disease, calcification or requiring surgery
Have received corticosteroids in the 30 days preceding screening
Have a history or physical examination finding that is incompatible with safe participation in the study
Have a history or physical examination finding that is incompatible with study product use
Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
Are taking medications that may significantly affect renal function